吸烟男性患者膝关节置换围手术期氨甲环酸应用的安全性

Safety of tranexamic acid in perioperative period of knee replacement in smoking male patients

目的:探讨吸烟男性患者围手术期静脉使用氨甲环酸的安全性。方法:通过前瞻性的临床对照试验,根据纳入和排除标准,筛选2017年1月至2020年12月在郑州大学第一附属医院行膝关节置换术的患者120例,分为3组,吸烟患者术中静脉应用氨甲环酸;吸烟患者术中不应用氨甲环酸以及不吸烟患者术中静脉应用氨甲环酸。纳入标准为,中重度骨关节炎患者,年龄60~80岁男性;初次膝关节置换术;患者及家属同意参加试验并签署知情同意书;试验组术前1年以上吸烟史,未戒烟;对照组无吸烟史或戒烟1年以上。排除标准为,双侧同时行膝关节置换术;术前无严重并发症;术前无影响凝血疾病;术前无影响凝血药物应用史;无氨甲环酸过敏;无膝关节感染。所有患者由同一主任医师行膝关节置换术,应用氨甲环酸患者在切皮前及假体装入后给予1.0 g氨甲环酸静滴。分别统计患者手术时间、术中出血量、术后引流量、隐性失血量、输血量、术前术后凝血指标、术后静脉血栓事件及并发症。采用χ^(2)检验、独立样本t检验进行数据分析。结果:吸烟与不吸烟患者应用氨甲环酸后术后Hct水平较均显著高于不应用氨甲环酸组患者(吸烟+氨甲环酸0.36±0.05,单纯吸烟组0.30±0.08,单纯氨甲环酸组0.35±0.10,t1=1.819,P1<0.01,t3=2.469,P3<0.05),且术后Hct变化值(吸烟+氨甲环酸0.12±0.02,单纯吸烟组0.18±0.05,单纯氨甲环酸组0.10±0.07,t1=7.047,P1<0.01,t3=5.882,P3<0.01)和Hb变化值[吸烟+氨甲环酸(45.5±12.0)g/dL,单纯吸烟组(55.0±8.4)g/dL,单纯氨甲环酸组(41.5±12.2)g/dL,t1=4.102,P1<0.01,t3=5.764,P3<0.01]差异有统计学意义,单纯吸烟组患者的术后引流量[(661.80±358.11)ml,t1=2.319,P1<0.05,t3=2.914,P3<0.01]、隐性失血量[(451.51±389.73)ml,t1=2.782,P1<0.01,t3=3.947,P3<0.01]及计算的总失血量[(1113.31±729.33)ml,t1=2.678,P1<0.01,t3=3.518,P3>0.05]均显著高于吸烟+氨甲环酸[术后引流量(500.82±254.11)ml,隐性失血量(261.22±187.73)ml,总失血量(752.03±442.82)ml]和单纯氨甲环酸组[术后引流量(463.13±240.34)ml,隐性失血量(197.21±119.14)ml,总失血量(660.35±362.48)ml],术后输血的概率也显著增高(吸烟+氨甲环酸7/33,单纯吸烟组18/22,单纯氨甲环酸组8/32,χ12=0.704,P1<0.01,χ32=5.698,P3<0.05),差异有统计学意义。结论:吸烟患者在关节置换术围手术期应用氨甲环酸可以显著的减少出血量和输血的概率,未显著增加患者深静脉血栓的发生率。

Objective To explore the safety of perioperative intravenous tranexamic acid in male smoking patients.Methods According to the inclusion and exclusion criteria,a total of 120 patients who underwent knee arthroplasty in our hospital from January 2017 to December 2020 were screened and divided into three groups:intravenous tranexamic acid was used in smoking patients;tranexamic acid was not used in smoking patients and tranexamic acid was used in non-smokers.Inclusion criteria were as follows:patients with moderate to severe osteoarthritis,men aged 60-80 years;initial knee replacement;patients and their family members agreed to participate in the trial and sign an informed consent form;the experimental group had a history of smoking more than 1 year before surgery and did not quit smoking;the control group had no history of smoking or quit smoking for more than 1 year.Exclusion criteria were as follows:simultaneous knee arthroplasty on both sides;no serious complications before the operation;no coagulation disease before the operation;no history of the use of coagulation drugs before the operation;no tranexamic acid allergy;no knee joint infection.All patients underwent knee arthroplasty by the same chief physician.Patients were given 1.0 g tranexamic acid intravenously before skin incision and after implantation of the prosthesis.Statistics of patients′operation time,intraoperative blood loss,postoperative drainage,hidden blood loss,blood transfusion,preoperative and postoperative coagulation indicators,postoperative venous thrombosis events and complications.The chi-square test and independent sample t-test were used for data analysis.Results The postoperative Hct levels of smokers and non-smokers after tranexamic acid were significantly higher than those in the non-tranexamic acid group(smoking+tranexamic acid:0.36±0.05;smoking only group:0.30±0.08;pure tranexamic acid group:0.35±0.10,t1=1.819,P1<0.01,t3=2.469,P3<0.05),and postoperative Hct changes(smoking+tranexamic acid:0.12±0.02;smoking only group:0.18±0.05;pure tranexamic acid group:0.10±0.07,P1<0.01,P2<0.01)and Hb change values(smoking+tranexamic acid:45.50±12.20;smoking only group:55.21±8.48;pure tranexamic acid group:41.50±12.20,t1=7.047,P1<0.01,t3=5.882,P3<0.01).Postoperative drainage(661.80±358.11,t1=2.319,P1<0.05,t3=2.914,P3<0.01),hidden blood loss[(451.51±389.73)ml,t1=2.782,P1<0.01,t3=3.947,P3<0.01]and calculated total blood loss[(1113.31±729.33)ml,t1=2.678,P1<0.01,t3=3.518,P3>0.05]were significantly higher than in smoking+tranexamic acid group[postoperative drainage volume(500.82±254.11)ml,hidden blood loss(261.22±187.73)ml,total blood loss(752.03±442.82)ml]and the tranexamic acid group[postoperative drainage volume(500.82±254.11)ml,hidden blood loss(197.21±119.14)ml,total blood loss(660.35±362.48)ml].The probability of postoperative blood transfusion was also significantly increased(smoking+tranexamic acid group:7/33;18/22 in the smoking group;8/32 in the tranexamic acid group,χ12=0.704,P1<0.01,χ32=5.698,P3<0.05).Conclusion The use of tranexamic acid in the perioperative period of joint replacement surgery in smoking patients can significantly reduce the amount of bleeding and the chance of blood transfusion,but does not significantly increase the incidence of deep vein thrombosis in patients.